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Lupus S - India CDSCO Medical Device Registration

Lupus S is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_ffbd381e4192ff2430ffbc48c593c755_1f4015798c0fb122ba94a137e59dd053. This device is marketed under the brand name Calset Vitamin D Total III. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
Lupus S
UID: IMP/IVD/2018/000038_ffbd381e4192ff2430ffbc48c593c755_1f4015798c0fb122ba94a137e59dd053

Brand Name

Calset Vitamin D Total III

Device Class

Class B

Approving Authority

CDSCO

Product Information

In vitro assays to screen for (Calset Vitamin D Total III) and to confirm (Calset Vitamin D Total III) the presence of lupus anticoagulants in citrated plasma on the indicated cobas t analyzers. The assay is intended as an aid in the diagnosis of anti phospholipid syndrome

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